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The Best Pharmaceuticals for Children Act, P.L. 107-109 BPCA was
signed into law January 4, 2002. BPCA renews and amends Section
111 of the Food and Drug Modernization Act. Provisions related
to OPT:
- Establishment of an Office of Pediatric Therapeutics and Ethicist
Position.
- Coordination and facilitation of all activities effecting the
pediatric population or practice of pediatrics or involving pediatric
issues.
- Requires monitoring of Adverse Events for drugs granted pediatric
exclusivity.
The Pediatric Research Equity Act, P.L 108-155 was signed into
law December 3, 2003. Provisions related to OPT:
- Requires that all applications for new active ingredients,
new indications, new dosage forms, new dosing regimens, and new
routes of administration must contain a pediatric assessment unless
the sponsor has obtained a waiver or deferral of pediatric studies.
- Established Pediatric Advisory Committee.
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Ethics
Guidance Documents
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